Automatic analyzer

ABSTRACT

An automatic analyzer and an automatic analyzing system to identify samples and reagents used in the analyzer and members used in measurement of at least two objects in common: system reagents or buffer solution; sensor parts; probes; nozzles; chips; dispensing cups; tubes; ISE electrodes; detectors; deionized water; and waste, and to unify management of identification information thereof and a measurement result.

This application is a continuation of U.S. patent application Ser. No.11/514,185, filed Sep. 1, 2006, now U.S. Pat. No. 8,245,907 B2 issued onAug. 21, 2012, the contents of which are hereby incorporated byreference into this application.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an automatic analyzer to performqualitative and quantitative analysis on biological samples such asblood and urine, and particularly to an automatic analyzer having afunction of easily examining a cause of data failure.

2. Description of the Related Art

In an automatic analyzer to perform qualitative and quantitativeanalysis on biological samples such as blood and urine, identification(ID) marks such as barcodes are attached on respective reagents andsamples (specimens), and information of the reagents and samples isautomatically registered in the analyzer by an ID mark reader, so as toprevent a mix-up of samples and use of a wrong reagent or a reagent forcontrolling accuracy (calibrator, control serum, etc.). The barcodeattached on each reagent may include a lot number of the reagent and ananalysis parameter or the like used to calculate a measurement valuewhen analysis is performed by using the reagent. Such an automaticanalyzer is disclosed in Patent Document 1 (JP, A 8-262029).

An analysis result of each sample is stored while being associated withthe lot number of a reagent used in the analysis, so that which lot ofreagent was used can be checked after the analysis.

SUMMARY OF THE INVENTION

The automatic analyzer is provided with ID information to identifystandard samples (standard specimens) and reagents. However, consumablesother than the samples and reagents are also used in analysis, forexample, buffer solution, disposable nozzle chips to be attached on thetop of a dispensing nozzle, dispensing cups, nozzles, tubes, ISEelectrodes, and detectors.

These consumables have conventionally been believed not to affect ananalysis result very much, and thus the conventional automatic analyzerdoes not have a function of identifying the lots of the consumables.

However, in the present circumstances where high analysis accuracy isrequired, even a slight deterioration of a tube may cause an abnormalmeasurement result. In that case, a lot of time is required to determinethe cause of abnormality in [.] the conventional analyzer.

An object of the present invention is to provide an automatic analyzerhaving a function of immediately finding a cause of abnormality occurredin an analysis result.

In order to achieve the above-described object, the present inventionhas the following configuration.

According to an aspect of the present invention, there is provided anautomatic analyzer including a storage unit for storing identificationinformation attached to consumables used in measurement of two or moretypes of samples in common and a measurement result obtained bymeasuring the samples by using the consumables, the consumableidentification information being associated with the measurement resultof the sample.

The consumables may preferably include at least one selected from agroup consisting of system reagents or buffer solution, sensor parts,probes, nozzles, chips, dispensing cups, tubes, ISE electrodes,detectors, and deionized water. The identification information maypreferably be manufacture lot numbers assigned by respective consumablesmanufactures, but may be information that is arbitrarily given by a userin accordance with the time of purchase. The above-described “used inmeasurement of two or more types of samples in common” means that, forexample, different sample are analyzed by using the same nozzle. Theconsumables are diversified ranging from those to be used for a longtime (for more than a year), such as nozzles and tubes, to nozzle chipsthat are replaced after several measurement. However, the consumablesare not limited as long as they are used in measurement of two or moretypes of samples.

Preferably, the automatic analyzer may further include a display unitfor displaying a list of a measurement result determined to be abnormaland the identification information of consumables used in themeasurement. “Displaying a list” means displaying a measurement resultand types and identification information of consumables in a table. Byseeing the list, the user can clearly recognize a relationship betweenconsumables having the same identification information and themeasurements performed by using the consumables.

The above-described configuration is not limited to one automaticanalyzer, but may be applied to a system in which a plurality ofautomatic analyzers are connected through a server or data servicecenter. In this case, if there exists a consumable used in measurementsdetermined to be abnormal in common in one of the automatic analyzers,the identification information of the consumable is transmitted to theother automatic analyzers, and identification information is given to aresult of analysis using the consumable specified by the identificationinformation. That is, a warning that the consumables of this lot mayhave a failure and thus the use thereof should be avoided or thatresults of the measurement that have been done may have an error can beprovided using an alarm warning unit.

Also, a data service center to manage information in which an analyzeris associated with identification information of consumables used in aplurality of items in the analyzer by using IDs (identifiers) may beprovided. The analyzer may include a unit to store a measurement resultin the analyzer and identification information of consumables in theanalyzer; and a unit to transmit the association information to the dataservice center connected thereto through a network. The data servicecenter may include a unit to receive the association information fromthe analyzer through the network; and a unit to store the receivedassociation information in a database provided in the center. That is,the management of consumables in units of lots can be performed not onlyin a hospital but also in units of local areas, prefectures, orcountries.

In the automatic analyzer, a cause of a problem which occurred duringmeasurement can be swiftly pursued and analyzed. As a result,countermeasures against the problem can be estimated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a conceptual view of a system according to the presentinvention;

FIG. 2 shows a schematic configuration of an analyzer and a data servicecenter according to the present invention;

FIG. 3 shows a method for registering an ID and a method for associatinga measurement result according to the present invention;

FIG. 4 shows a method for identifying and determining consumables whendata failure occurs according to the present invention;

FIG. 5 shows an example of a configuration of an automatic analyzeraccording to the present invention; and

FIG. 6 shows a screen displaying a measurement result and informationabout consumables according to the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

First, a configuration of an automatic analyzer according to the presentinvention is described with reference to FIG. 5 by using a pipettor-typeanalyzer as an example. In reaction containers 76 b arranged in areaction site 35B of the analyzer, reaction of samples and reagentsregarding a predetermined analysis item progresses. A sample rack 31 isplaced at a pipetting position, a specified sample is pipetted by apipette nozzle of a sample pipettor 78 b, and a predetermined amount ofthe sample is ejected into the reaction container 76 b. The samplepipettor 78 b includes a sampling pipettor pump 77 b. The reaction site35B is kept at a constant temperature (e.g. 37° C.) by a thermostaticliquid supplied from a thermostatic chamber 40.

A pipettor-type reagent supplying unit 56 of the analyzer shown in FIG.5 includes two reagent disks 55A and 56B for first and second reagents.Reagent bottles 42A and 42B containing various reagents prepared formany analysis items are attached with barcodes serving as reagent IDinformation on their outer walls. After the reagent bottles 42A and 42Bhave been placed in the reagent disks 55A and 56B, the reagent IDinformation attached on each reagent bottle is read by a barcode reader53A or 53B, and the read information is stored in a storage unit 7together with the set position on the reagent disk of the reagentbottle, a corresponding analysis item, and the number assigned to theanalyzer in which the reagent bottle is set. Reagent pipettors 38A and38B include a reagent pipettor pump 41 connected to each pipette nozzlethat can rotate and move vertically.

The array of the reaction containers 76 b in which samples have beenpipetted is rotated, a predetermined amount of first reagent is pipettedby the reagent pipettor 38A from the reagent bottle 42A positioned at apipetting position in accordance with an analysis item, and the firstreagent is ejected into the reaction container 76 b placed at a reagentadding position. After the content has been stirred by a stirringmechanism 43A at a stirring position, the array of the reactioncontainers is conveyed a plurality of times. When the reaction container76 b reaches a second reagent adding position, the reagent pipettor 38Bpipettes the second reagent from the reagent bottle 42B positioned at apipetting position in accordance with an analysis item and ejects thereagent into the reaction container. Then, the content in the reactioncontainer is stirred by a stirring mechanism 43B. Then, a light fluxfrom a light 44 b passes through the reaction container 76 b inaccordance with the rotation of the array of the reaction containers,and the light flux passed through the reaction liquid in the reactioncontainer 76 b is detected by a multiwavelength photometer 45 b. Asignal having a wavelength corresponding to the analysis item isprocessed by a logarithmic converter 60 b and an A/D converter 61 bcontrolled by a computer 36B on the analyzer side, and a digital signalis transmitted to a computer 36B for entire control. The reactioncontainer 76 b after measurement is cleansed by a cleansing mechanism 49b and is reused.

In the above-described automatic analyzer, consumables include those tobe refilled, exchanged, or disposed by a user, for example, buffersolution; chips; dispensing cups; nozzles; tubes; ISE electrodes;detectors; deionized water; and waste.

When ID information is to be applied (identification) to theconsumables, the following methods can be used. For example, a barcodeissuing unit is provided on the analyzer and IDs of the respectiveconsumables are stored in the analyzer by radiation, as in conventionalregistration of reagent information. Alternatively, ID lattices (chipsor IC tags) may be embedded in the consumables in advance and theinformation may be provided to the analyzer wirelessly.

Hereinafter, an embodiment of the present invention is described withreference to FIG. 2. An abnormal measurement result caused by aconsumable can be instantaneously determined by displaying a measurementstatus and consumables information, received from an alarm warning unit14, in an operation screen 8 during measurement. Information 9 includinga measurement result and consumables information associated with eachother is transmitted to a data service center 4 after authentication ina user ID authenticating unit 10. Then, the information 9 including themeasurement result and the consumables ID information used in themeasurement is tallied and sorted by a tally/sort unit 11, several stepsare preformed, and management of the data is unified. The data ismanaged while being stored in a data storing area 13 of a database 12 inthe service center 4 in units of facilities, and respective measurementresults are constantly stored. If data of a measurement result isdifferent from existing data, the data is transmitted from the datatally/sort unit, through the alarm warning unit to an NG analyzer 15,where the cause is analyzed. In the analysis, an analysis profilestoring area 16 is searched for the same pattern. If a history exists,NG profile information is transmitted to an information storing unit 7in the analyzer and is stored in the analyzer so that the same symptomdoes not occur again. If the same pattern is not found, a new NG profileis generated by a new NG profile generating unit 18 on the basis of theanalysis profile. The generated NG profile is written in an analysisprofile storing area 16 and is transmitted to the information storingunit 7 in the analyzer so as to be stored therein.

First Embodiment

<Method for Registering ID and Method for Associating MeasurementResult>

A trouble due to a consumable member used in common to measure at leasttwo objects is explicitly notified to a user, who is then encouraged totake countermeasures.

An example is described by using a system reagent with reference to FIG.3.

First, reagents are registered in step S1. A handy barcode reader isattached on the analyzer so that lot information of system reagents canbe easily registered. Alternatively, identifiers Oa chips or IC tags)are embedded in consumables, information thereon is read wirelessly, andsystem reagent information is registered in the analyzer. In order tolimit item reagents, 1) a standard range of a general sample in eachitem is input; and 2) an expected value (desired value) of each sample(Control-Calibration) is input. Then, lot information is recorded orstored. Information about consumables used in common to measure at leasttwo objects is stored by item, measurement condition, and time, and theinformation is stored in the analyzer.

In step S2, measurement is performed and a measurement result isobtained.

In step S3, the system reagent used in the measurement is specified andis stored, and it is determined whether association is necessary in themeasurement result. Also, 1) it is determined whether the sample is acontrol sample or a calibrator sample, and 2) measurement is performed aplurality of times on a specimen in which the sample is a generalsample. Then, after an average of measurement values has been obtained,it is determined whether the average exceeds the expected value of thespecimen.

If the measurement result is NG, the process proceeds to step S4, whereassociated lot information of the measurement result requiringassociation is searched for.

In step S5, the associated lot information is displayed on the operationscreen while being associated with the measurement result (5). Anexample of the screen displayed is shown in FIG. 6. In addition toinformation about a measuring instrument; date and time of measurement;and a measurement item, information about respective consumables arelisted on the screen. Accordingly, abnormality caused by a combinationof consumables used in the measurement can be determined. Whenabnormality occurs, the abnormal part blinks so that the user canrecognize a part to be inspected. Incidentally, measurement resultsobtained by using different combinations of consumables can be comparedand the comparison result can be held as reference data in the device.That is, a measurement result and information about consumables used inthe measurement are displayed together on the operation screen.

Finally, in step S6, causes of the abnormality are estimated on thebasis of the association, possible causes are ranked, andcountermeasures against each of the estimated causes are displayed onthe operation screen.

In this way, steps S1 to S6 are performed, so that registration of IDsand association of a measurement result complete.

Second Embodiment

<Relationship Between Data Service Center and Analyzers>

Hereinafter, the definition of the data service center in the presentinvention is described with reference to FIG. 2.

The data service center 4 connects to a plurality of analyzers 2 througha network 3 and serves as an agency to store measurement results in therespective analyzers and information about the consumables used. Thecenter 4 is provided with the database 12 to accumulate the information9 including the measurement results obtained from the analyzers 2 and IDinformation of the consumables used. The database 12 receives theinformation 9 from each of the analyzers 2. The information 9 receivedby the database 12 is stored in units of users. Also, the information 9is stored while being sorted by analyzer, analysis item, and informationabout consumables. A user can access history information by inputtinghis/her user ID in the user ID authenticating unit 10. Also, an averageof measurement values received from the automatic analyzers 2 iscalculated, measurement results and information about consumables in aplurality of combinations are statistically analyzed, and tendency andpattern are transmitted to the analyzers so as to be stored therein. Ifan abnormal measurement result due to a consumable is generated, amethod for avoiding the trouble is distributed or transmitted throughthe network.

Third Embodiment

<Method for Identifying and Determining Consumables at Data Failure>

A method for identifying and determining consumables at data failure isdescribed with reference to FIG. 4.

In step S1, the information 9 including measurement results associatedwith the name of an item, an expected value, an actual value, andconsumables, is transmitted from an inspection facility 1 to the dataservice center 4 through the network 3.

In step S2, the database 12 in the center 4 receives the information 9from the analyzers in each inspection facility.

In step S3, the measurement results and information about consumablesare accumulated in the database 12 in the center 4.

In step S4, a common point in the plurality of analyzers is searched forand is analyzed.

In step S5, countermeasures are taken on the basis of the informationfound in step S3.

In step S6, the center 4 transmits the countermeasures and warning,using the alarm warning unit 14, to the analyzers 2. In step S7, historyinformation stored in the data storing area 13 in the center 4 isbrowsed.

Finally, in step S8, the analyzers 2 receive the countermeasures andwarning from the alarm warning unit, as transmitted in step S6 and thehistory information browsed in step S7.

By performing the above-described steps S1 to S8, the method foridentifying and determining consumables can be performed when datafailure occurs. By unifying management of measurement results obtainedfrom analysis and consumables used in the measurements by usingidentifiers, the cause of a trouble can be specified even if the troubleoccurs. Furthermore, countermeasures against the trouble can bedetermined.

Fourth Embodiment

Analysis Program

NG results transmitted from a plurality of inspection facilities 1 tothe data service center 4 are tallied up and the statistics arecalculated.

The statistics are calculated by using an analyzing tool in each of (1)overall tendency; (2) weekly report; (3) monthly report; (4) annualreport; (5) lot number; and (6) measurement item. The calculatedstatistics are stored in the analysis profile area 16 in the database 12provided in the service center 4.

If a measurement result does not match that stored in the informationstoring unit 7 in the analyzer 2, the measurement result is transmittedto the data service center 4 and the analysis profile storing area 16 isautomatically searched.

If a measurement result matches a result example stored in theinformation storing unit 7 in the analyzer 2, the measurement result istransmitted to the data service center 4 and is stored in the datastoring area 13 in the database 12 provided in the service center 4.

If it is not sure whether a data failure is due to measurement or due toa lot, measurement is performed again by using another lot or anotherreagent.

If data failure is determined in the analyzer, information thereof isstored in the system so that the data is automatically masked if thedata is to be used.

What is claimed is:
 1. An automatic analyzer system comprising: pluralkinds of consumables used in common to measure at least two samples,said plural kinds of consumables including at least two consumablesselected from a group of consumables including nozzle chips, dispensingcups, nozzles, tubes, ISE electrodes, and detectors, each consumableincluding an identifier including consumable identification information;a plurality of automatic analyzers, each automatic analyzer including: ameans for reading the consumable identification information; aninformation storing unit for storing consumable identificationinformation of consumables used in common to measure at least two kindsof samples read by the means for reading, and for storing measurementresult values of each of a plurality of samples measured in eachautomatic analyzer by using said consumables; a controller having aprogram configured to execute the steps of: associating the consumablesidentification information with said measurement results for each ofsaid at least two kinds of samples in each of the plurality of automaticanalyzers, and transmitting the association information to a dataservice center connected thereto through a network and wherein the dataservice center is connected to each of said plurality of automaticanalyzers through a network, said data service center including: aninformation storing unit for storing information associated with thename of a sample, an expected measurement result value, an actualmeasurement result value and consumable identification informationassociated with measurement results of each of the plurality of samplesmeasured by using said plurality of consumables in each of saidautomatic analyzers and sent to said data service center from each ofsaid plurality of automatic analyzers through the network, an alarmwarning unit for communicating alarm information to each of saidplurality of automatic analyzers on the basis of said plurality ofconsumable identification information of said consumables when there isa consumable which is used in common in measurements and which isdetermined to be abnormal in one automatic analyzer, the alarminformation being transmitted by the data service center to other onesof the plurality of automatic analyzers using the consumable determinedto be abnormal, said data service center further having a controllerincluding a program configured to execute the steps of: receiving andstoring the information associated with the name of a sample, the actualmeasurement result value of the sample, and the consumableidentification information for the plurality of consumables from one ofthe plurality of automatic analyzers used in the measurement; searchingsaid received information stored in the data service center informationstoring unit to find consumables used to measure at least two kinds ofsample whose actual measurement result is judged to be abnormal in oneof the plurality of analyzers; transmitting alarm information to each ofthe other ones of the plurality of automatic analyzers on the basis ofsaid plurality of consumable identification information of saidconsumables when there is a consumable which is used in common inmeasurements and which is determined to be abnormal in one automaticanalyzer; and constructing a countermeasure for the cause of theabnormality and transmitting the countermeasure to the one of theplurality of automatic analyzers transmitting the abnormal measurementresult.